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Needle dislodgement – The Issue

Needle dislodgement – The Issue. In the US alone, more than; 2 / 2 / 200 2 patients die due to VND every week 2 patients are seriously injured every day due to VND 200 needles are dislodged every day RPA estimates that 1 in 720 hemodialysis treatments performed in the US has a VND 4

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Needle dislodgement – The Issue

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  1. Needle dislodgement – The Issue • In the US alone, more than; 2 / 2 / 200 • 2 patients die due to VND every week • 2 patients are seriously injured every day due to VND • 200 needles are dislodged every day • RPA estimates that 1 in 720 hemodialysis treatments performed in the US has a VND4 • Haemodialysis nurses tells that they believe dislodgement related incidents are often not reported2 • It is estimated that 136 patients die annually, in the US alone, due to venousneedle dislodgement1 • VA clinics reports that 1 of 62500 treatments result in a serious bleeding and in worst case death 3 • After a VND, the patient has a higher risk of mortality, due to infections5 • Sandroni S. Catastrophic Hemorrhage from Venous needle dislodgement during hemodialysis. Journal of the American Society of Nephrology, volume 19, November 2008 • Nyteknik, issue 33, 15th August 2007 • Patients Safety Advisory; Veteran Health Administration Warning System; Published by VA Central Office; October 21, 2008 • Renal physicians association, US, patient survey 2007 5) Gambro, France

  2. Market Potential Patient population approximatly 2 mil ESRD patients 89% are treated with HemoDialysis (HD) 1.8 million 362 000 HD 271 500 HD 270 000 HD 900 000 HD AisaPaciffic Latin America & Other North America incl. Canada EU, Africa & Middle East 270 million HD treatmentsannually

  3. Where are our markets? • Market size • Sweden – 3 500 patients • UK – 20 000 patients • Germany – 65 000 patients • USA – 300 000 patients • Market structure • Safety a concern? • KOL • Organization of customers • Regulatory • Legal • Accessibility • Ways to market (Regulatory bodies, distributors/agents Interests grps) • Speed of adoption

  4. It’s a regulatory must!

  5. Redsense – reducescost for the Health care system

  6. Let’s roll • USA – direct sales • Germany – direct sales (but later) • UK – distributors (started w direct sales) • Europe – distributors • Asia – wait (different regulatory) • Australia – distributor (large on self HD)

  7. Customers Samplesofkeycustomers: • USA gov. ofVeterainAffairs • Firstclinicstarted 2008 • All clinicsmandatory from Nov. 9 ’10 • Appr. 20% adaptation • Scotland • startedusing RS 2009 • Appr. 15 -18% adaptation • Cleveland clinics • acute hospital, • started 2010 • Art. Publ. Nov 2011 • Used by all AVF/Grafs • FMC-NA • Nocturnaluse

  8. Reflections • Do you need to be best in class? • Governmental bodies • Läkemedelsverket • FDA • Veteran Affairs • Funds • Business Angels • VC • Vinova, Almi

  9. Tack! Summery • Market acceptance • CE March 2007 • FDA clearance clinic Oct 2007 • FDA clearance home May 2010 • Redsense is being sold in 13 countries: • Sweden, USA, Canada, Denmark, Finland, Germany, Holland, Belgium, France, Italy, Spain, Austria, Australia • Examples of clinics: • Cleveland clinics, VA-hospitals, Glasgow (all of Scotland), NÄL, Skejbyetc Patrik.Byhmer@redsensemedical.com

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